Immune Response Following COVID-19 Vaccination (IFVAC)
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Post-vaccination immune response
研究概览
简要总结
Few trials have reported the safety and efficacy of the COVID-19 vaccines. However, these trials were mostly focused on post-vaccination adverse events and short-term antibody detection with none monitoring the presence of immunoglobulin G (IgG) in blood at long-term follow-up after the vaccination. This study aims to evaluate the immune response in post-vaccinated individuals across a follow-up period of one year.
详细描述
The COVID-19 pandemic started in December 2019 and since then has spread globally claiming over 550, 000 deaths, >12 million infections and an economic toll in the trillions of dollars to date. The urgent need for a global vaccination program to control this pandemic has prompted the development of several vaccines.
Preliminary reports from few trials evaluating the safety and efficacy of the vaccines have been published (2-4).
However, no trials have yet reported the long-term post-vaccination immune response that would potentially determine the necessity and timing for booster doses of the vaccine.
Therefore, this study is designed to assess the presence of immunoglobulin (Ig) M and G at several time points after the first and the second dose of the vaccine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals that have received first dose of COVID-19 vaccine
排除标准
- •Unwilling to provide informed consent
- •Unwilling for the follow-up serological test during the 1-year enrollment
结局指标
主要结局
Post-vaccination immune response
时间窗: 1 year
To assess the time for appearance and persistence of IgM and IgG after COVID-19 vaccination.
次要结局
未报告次要终点
研究者
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation